Fascial Versus Standard Neck Dissection in Patients With N1b Papillary Thyroid Carcinoma

Completed

• Conditions: Patients With Papillary Thyroid Cancer and N1b Status
• Interventions: Procedure: Standard Neck Dissection; Procedure: Fascial Neck Dissection

• Registration Number: NCT05804682
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Optimal surgical technique for neck dissection (LND) in thyroid carcinoma remains a subject of debate. Fascial ND (FND) implies the removal of the superficial and middle layers of the deep cervical fascia en bloc with lymph-nodes containing fibro-fatty tissue (levels IIa-Vb and VI-VII for cN1b patients). This retrospective cohort study was designed to compare FND with standard, non-fascial, selective ND (SND).

Detailed Description

In thyroid cancer patients, lymph node dissection includes a comprehensive removal of all the target nodal basins: anterior cervical compartment (level VI) and the superior mediastinal nodes that can be reached via cervical incision (level VII) in CND, and levels IIa-Vb in LND. Clearance of those levels without including the enveloping fasciae in the specimen is referred to hereafter as Standard Neck Dissection (SND), as it is the most common technique applied for thyroid tumors. In Fascial Neck Dissection, the comprehensive clearance of the target basins is achieved by following the planes of coalescence of the cervical fascial layers. Those are avascular and enable the removal of the target nodes en bloc with their investing fascial layers.

The aim of this retrospective study was to compare the outcomes between fascial and standard approach in N1b PTC patients that underwent surgery for N1b papillary thyroid cancer. The primary objective was to achieve a significantly higher nodal yield by applying the fascial neck dissection technique and reduce rates of early loco-regional recurrence. Secondary objectives were the evaluation of short and long-term post-operative complications and the cosmetic result.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-12-31
• Status Verified: 2022-03
• Study Completion: 2023-01-31
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Patients who met all the following criteria were eligible for inclusion in this retrospective evaluation:

• Male or female patients, living or deceased, aged 18 years or older at the time of operation
• Unilateral (left/right) or bilateral lateral neck dissection along with central neck dissection
• Patients with papillary cancer, pN1b. This excludes patients with other types of thyroid cancer (e.g., medullary, follicular, and anaplastic);
• Patients that underwent central and/or lateral neck dissection as a primary intervention. This excludes patients with any previous operation for thyroid disease involving any type of lymph node dissection.

Exclusion criteria: patient's age < 18 years, patients that underwent previous neck dissection of any type and patients who refused or were unable to provide adequate follow up data.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients that underwent ftandard dissection for N1b papillary thyroid cancer	Standard Neck Dissection	-
Patients that underwent fascial dissection for N1b papillary thyroid cancer	Fascial Neck Dissection	-

Primary Outcome Measures

Name	Time	Method
Harvested lymph nodes	Interventions 2018-2021, Final follow up January 2023	Total and positive lymph node yields for central and lateral compartments
Early loco-regional recurrence	Interventions 2018-2021, Final follow up January 2023	Locoregional recurrence within 1 year from operation

Secondary Outcome Measures

Name	Time	Method
Early and late complications	Interventions 2018-2021, Final follow up January 2023
Voice and swallowing score comparisons	Interventions 2018-2021, Final follow up January 2023
Cosmetic outcome	Interventions 2018-2021, Final follow up January 2023

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy